Bauman Rigid Laryngoscope
FDA 510(k) K901680 · Palex Intl. SA
510(k) numberK901680
Submission
- Device name
- Bauman Rigid Laryngoscope
- Applicant
- Palex Intl. SA
Spain, ES - Received
- April 12, 1990
- Decision date
- July 12, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCW – Laryngoscope, Rigid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5540
- Specialty
- Anesthesiology
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|---|---|---|---|
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| K062231 | MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001CCW · Special | Minrad, Inc. | 08/31/2006SE |
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| K041852 | MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002CCW · Traditional | Minrad, Inc. | 11/15/2004SE |
| K984101 | FlexibladeCCW · Traditional | Arco Medic , Ltd. | 09/03/1999SE |
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Questions and answers
When was Bauman Rigid Laryngoscope cleared by the FDA?
Bauman Rigid Laryngoscope (K901680) received a 510(k) decision of Substantially Equivalent on July 12, 1990, 91 days after the submission was received.
What is the product code of K901680?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.